GRiP Tools for Interoperability Questions and Considerations for - - PowerPoint PPT Presentation

GRiP – Tools for Interoperability

Questions and Considerations for Ethics Committees Evaluating Paediatric Drug Trials

Allison Needham Anne Junker The Hospital for Sick Children in Collaboration with GRiP Partners

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GRiP project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 261060

Aims

1) To collect and evaluate available guidance on key issues identified by EC’s during the ethical evaluation of pediatric research. 2) Synthesize the appraised guidance to prepare a document outlining the specific questions that need answering and the considerations that should be made in the ethics review of paediatric clinical trial research

GRiP project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 261060

Process

1) Invite experts – ethicists with ped expertise 2) Select 5 main ethics questions for pediatric drug trial ethics review 3) Collect guidance 4) Conduct content and quality appraisal of guidance 5) Synthesize guidance to prepare ‘layered’ document 6) Pilot tool and obtain feedback 7) Finalize tool and explanatory document

GRiP project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 261060

Task Working Group

• Francis Crawley – Executive Director, GCP Alliance
• Robert “Skip” Nelson – Deputy Director and Senior Pediatric

Ethicist, FDA

• Hugh Davies – Paediatrician and National Ethics Advisor, NRES

UK

• Bobby Farsides – Professor of Clinical and Biomedical ethics

and Chair, Nuffield Bioethics

• Pau Ferrer - Professor of Bioethics, member of International

GCP working group

• Allison Needham, MSc supported by Martin Offringa,

Professor of Pediatrics and Head, Child Health Evaluation Sciences Unit, Sick Kids Research Institute, Canada

GRiP project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 261060

What are the key pediatric specific questions that should be asked during the ethics review of a drug trial protocol?

GRiP – YPAG

International consensus guidelines for the formation of young person advisory groups

Winnie Chan Anne Junker The Hospital for Sick Children in Collaboration with GRiP Partners

GRiP project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 261060

Disclaimer

• I am not a member of GRiP
• I am not a member of this Task Working Group
• I have not first-hand contributed content to the

developing guidance

 I do oversee a YPAG and the program guidance  I am involved in review and advice about the

international consensus guideline and website

GRiP project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 261060

Rationale for YPAG:

Avoidance of Waste in the Production and Reporting of Research Evidence

Iain Chalmers, Paul Glasziou Lancet 2009;374:86-89.

GRiP project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 261060

Aims

1) To develop guidance for ‘best practices’ to create Young Person Advisory Groups 2) To make this information broadly available

GRiP project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 261060

Process

1) Invite the experts 2) Collect existing guidance from current YPAGs 3) Conduct content and quality appraisal of guidance 4) Synthesize guidance to prepare document and website 5) Pilot and obtain feedback 6) Launch!

GRiP project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 261060

Task Working Group

• existing YPAGs

– UK Clinical Research Network: Children Specialty – Scottish Children’s Research Network – Young Persons Advisory Group (YPAG), Vancouver, Canada – Kids and Families Impacting Disease Through Science (KIDS) of the American Academy of Pediatric (AAP) in the USA

• Dr. Cor Oosterwijk, vice-president of the European Genetic

Alliances' Network patient and public involvement expert,

• many fellow GRiP members
• Winnie Chan, MPH supported by Martin Offringa, Professor
• f Pediatrics and Head, Child Health Evaluation Sciences Unit,

Sick Kids Research Institute, Canada

GRiP project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 261060

This presentation reflects only the author(s)’s views and the Union is not liable for any use that may be made with the information contained therein.